Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects
- Registration Number
- NCT00446043
- Lead Sponsor
- Galderma R&D
- Brief Summary
This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.
Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.
Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 452
- A clinical diagnosis of acne vulgaris with facial involvement.
- A minimum of 20 but not more than 50 Inflammatory lesions.
- A minimum of 30 but not more than 100 Noninflammatory lesions.
- Subjects with presence of nodules or cysts.
- Acne conglobate, acne fulminans, secondary acne, or severe acne.
- Underlying diseases that required the use of interfering topical or systemic therapy.
- Use of prohibited medications prior to the study unless appropriate washout period was documented.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adapalene/Benzoyl Peroxide Adapalene/Benzoyl Peroxide Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.
- Primary Outcome Measures
Name Time Method Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6 At Month 6 Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF Baseline, Month 12 LOCF Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF).
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12 At Month 12 Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
- Secondary Outcome Measures
Name Time Method Number of Participants With Local Tolerability Assessment For Erythema Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe.
Number of Participants With Local Tolerability Assessment For Scaling Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a "0" (none) to "3" (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production).
Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) Baseline up to Month 14 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Local Tolerability Assessment For Dryness Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness).
Number of Participants With Local Tolerability Assessment For Stinging/Burning Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 Local tolerability assessment for stinging/burning \[prickling pain sensation immediately after (within 5 minutes of) dosing\] was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort).
Number of Participants With Clinically Significant Abnormal Laboratory Parameters Baseline up to Month 14 Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported.
Trial Locations
- Locations (1)
Phoebe Rich, MD
🇺🇸Portland, Oregon, United States